NCT07667608Not yet recruiting
Ultrasound Assessment of Diaphragmatic Structure and Function in Patients With Liver Cirrhosis: A Point-of-Care Tool for Predicting Complications and Sarcopenia in Limited Resource Settings
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
The goal of this observational study is to learn how liver cirrhosis affects the diaphragm, the main muscle used for breathing, in adults. The study will measure diaphragmatic thickness, thickening fraction, and excursion using bedside ultrasound and compare these values between patients with cirrhosis and healthy volunteers. The main questions it aims to answer are: Do patients with cirrhosis show reduced diaphragmatic function compared to healthy adults? Does removal of ascitic fluid by paracentesis improve diaphragmatic mechanics? Can ultrasound measurements of the diaphragm serve as a reliable non-invasive marker of sarcopenia when compared to CT scans? Participants will: Undergo diaphragmatic ultrasound during quiet and deep breathing Provide clinical and laboratory data related to liver disease severity In some cases, have ultrasound repeated before and after paracentesis For patients with hepatocellular carcinoma, CT scans will be analyzed to measure muscle mass
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 16 Jun 2026
- Start date
- 10 Aug 2026
- Primary completion date
- 10 Aug 2027
- Lead sponsor
- Assiut University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07667608
What you commit to
- Study type: Observational
- Planned participants: 120
- From 10 Aug 2026 to the primary completion date, 10 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent thoracic surgery, thoracocentesis within the preceding 72 hours, or thoracic trauma.
- Inability to achieve adequate ultrasound acoustic windows (e.g., due to extreme obesity or surgical dressings).
- Prior or planned liver transplantation within the study period, which would confound longitudinal follow-up.
Other illness
- Significant pre-existing primary pulmonary disease (e.g., moderate-to-severe COPD defined as FEV1/FVC \<70% with FEV1 \<60% predicted, interstitial lung disease, pulmonary fibrosis) that independently affects diaphragmatic mechanics.
- Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré syndrome) independently affecting diaphragmatic function.
Other
- Active mechanical ventilation at time of enrollment.
- Pregnancy.
- Contraindications to paracentesis in Subgroup A (e.g., disseminated intravascular coagulation, bowel obstruction).
- Refusal or inability to provide informed consent.
Who the study is looking for
- Age ≥18 years.
- Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, histological, or imaging criteria.
- Ability to provide written informed consent in Arabic or English.
- For Subgroup A: clinical indication for large-volume paracentesis with an ascitic volume of ≥5 liters.
- For Subgroup B: confirmed hepatic hydrothorax or confirmed absence of pleural effusion on ultrasound or chest X-ray.
- For Subgroup C: radiologically confirmed HCC by triphasic CT or MRI according to EASL/AASLD diagnostic criteria, with available CT imaging for L3 SMI analysis.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.